Ultraverse® 035 PTA Dilatation Catheter U3513064Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 6.0mm x 40mm balloon, 130cm shaft · Class 2
All models of Ultraverse 035 PTA Dilatation Catheter (92)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741093173), received between Oct 11, 2022 and Aug 5, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Device-Device Incompatibility1
- Difficult to Insert1
- Failure to Advance1
- Leak/Splash1
- Material Deformation1
- Material Rupture1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY LEAKING AT THE SHAFT LEVEL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717696 ↗MalfunctionJun 18, 2025Difficult to Insert; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Difficult to Insert; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING ULTRAVERSE 035. DURING THE PROCEDURE, AFTER FLUSHING THE GUIDEWIRE LUMEN AND INSERTING THE BALLOON, THE SURGEON FOUND THAT THE TAIL END OF THE BALLOON WAS SIGNIFICANTLY BENT. AN ATTEMPT WAS MADE TO INSERT IT INTO THE SHEATH, BUT THE BENDING BECAME MORE SEVERE DURING DELIVERY. REPORTEDLY BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH. THE SURGEON THEN RETRIEVED THE BALLOON, WHICH WAS CLOSE TO BREAKING, AND SELECTED ANOTHER PRODUCT OF THE SAME MODEL TO COMPLETE THE SURGERY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22281442 ↗MalfunctionDec 6, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 3 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18273989 ↗MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PREPARATION OF AN ANGIOPLASTY PROCEDURE, WIRE ALLEGEDLY BROKE IN HALF UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15578947 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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